Indian Supreme Court seeks details of all clinical trials in country

The Supreme Court Monday asked the central government to provide details of clinical trials being conducted throughout the country, their side effects and deaths, if any.

A bench of Justice R.M. Lodha and Justice Anil R. Dave, while asking the central government to furnish the details, also issued notice to all state governments, seeking to know whether they were being kept in the loop regarding clinical trials in their states.

The court asked the central government to furnish the details of number of applications received by Directorate General, Drugs and Cosmetics, for clinical trials from Jan 1, 2005 to June 30, 2012.

It also asked the government to furnish details of the number of patients who suffered side effects on account of these clinical trials and the nature of these side effects.

The court also sought information on the number of patients who died on account of these clinical trials and the compensation that was paid to these people who suffered side-effects or their next of kin in case of deaths.

The court wanted to know if the states have any special laws or regulations to regulate clinical trials.

Leaving none in doubt about its seriousness, the court said: “We are very serious about the matter. We can pass one line order asking all these clinical trials which effects many people must stop forthwith.”

Expressing its anguish that these trials related to people, it said: “We are concerned about the lives of human beings who become subjects of clinical trials unknowingly and helplessly, pointing to the process of malpractices by doctors and drug companies.”

The court declined to accept the Madhya Pradesh government’s plea that the state government was in the dark about clinical trials being conducted in the state.

As senior counsel Dushyant Dave told the court that the stare government was not aware of these clinical trials as they were permitted by the directorate general, Drugs and Cosmetics, it said clinical trials were being conducted in government hospitals by their doctors and it was difficult to accept that the state government was totally unaware of it.

The court was hearing a public interest litigation by a Madhya Pradesh-based NGO Swasthya Adhikar Manch, which pointed to clinical trials being conducted in Madhya Pradesh without patients being aware that they were subjects of such trials.

The court Feb 6 this year had issued notice to the central government on a plea seeking investigation into illegal and unethical clinical trials of new drugs which are yet to be introduced in the country.

Swasthya Adhikar Manch had contended that in a large number of cases, multinational corporations were using contract research organizations for carrying out clinical trials of their drugs which are yet to be listed.

“These organizations are created by MNCs and they (the MNCs) outsource to these organizations the purpose of obtaining consent for conducting clinical trials,” the NGO alleged adding that “all these MNCs operate through these committees”.

The NGO had claimed that as a consequence of these illegal clinical trials 1,727 patients have died in four years from 2007 to 2010.